abstract：:An extensive global system of private food regulation is under construction, one that exceeds conventional regulation thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been ...

journal_title：Food and drug law journal

authors： Halabi SF,Lin CF

更新日期：2017-01-01 00:00:00

abstract：:The regulation of food, drugs, and controlled substances in this country is exceedingly complex. Local, state, and federal regulation coexist, and common law remedies supplement positive law. Strata of regulation are necessary because patterns of production and consumption vary by region and demographic, while federal...

journal_title：Food and drug law journal

authors： Winters DRH

更新日期：2016-01-01 00:00:00

abstract：:This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponsors’ innovation incentives and that access facilitates new drug development. The...

journal_title：Food and drug law journal

authors： Kim D

更新日期：2016-01-01 00:00:00

abstract：:One might expect--given the vastly different look, feel, and function of the ubiquitous (and innocuous) Nutrition Facts panel and the "inflammatory" graphic warning labels for cigarettes--that the statutes establishing such disclosure requirements would exhibit similar disparities. In fact, the relevant provisions of ...

journal_title：Food and drug law journal

authors： Weimholt J

更新日期：2015-01-01 00:00:00

abstract：:The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation sequencing, to the agency's Part 812 investigational device exemption (IDE) regulation. Genome sequencing--for reasons expla...

journal_title：Food and drug law journal

authors： Evans BJ

更新日期：2015-01-01 00:00:00

abstract：:The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory ...

journal_title：Food and drug law journal

authors： Coleman TS

更新日期：2014-01-01 00:00:00

abstract：:The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it ...

journal_title：Food and drug law journal

authors： Seidman B

更新日期：2014-01-01 00:00:00

abstract：:The Federal Food, Drug, and Cosmetic Act ("FDCA"), amended in 1990 by the Nutrition Education and Labeling Act ("NLEA"), established a national framework for the administration and promulgation of uniform food labeling standards. Specifically, the NLEA created affirmative obligations for the food--requiring detailed d...

journal_title：Food and drug law journal

authors： Springer J

更新日期：2013-01-01 00:00:00

abstract：:Pharmaceutical companies use social media such as Facebook and Twitter more and more to advertise their products. Advertising of medicinal products especially in social media is a critical issue confronting patient protection, competition law and ethical concerns in direct-to-consumer advertising. Advertising in the W...

journal_title：Food and drug law journal

authors： Buechner B

更新日期：2013-01-01 00:00:00

abstract：:This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA). In addition, the government pursued actions against individual executives under the Responsible Corporate Officer Doctrine...

journal_title：Food and drug law journal

authors： Reiss JB,Crowder D,Simons B,Pleskov I,Davis T,Nugent P

更新日期：2012-01-01 00:00:00

abstract：:While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectivenes...

journal_title：Food and drug law journal

authors： Fox B

更新日期：2012-01-01 00:00:00

abstract：:Government-provided exclusivity periods provide pharmaceutical companies with incentives to invest in new drugs. Meanwhile, encouraging competition serves another worthy goal of improving the affordability of medications. Decades ago, the Hatch-Waxman Act set forth provisions attempting to balance these objectives in ...

journal_title：Food and drug law journal

authors： Gaudry KS

更新日期：2011-01-01 00:00:00

abstract：:A biosimilar contains an active ingredient that is similar, but not identical, to the active ingredient in an approved reference drug. This raises the issue of when and how a biosimilar should be allowed to compare to a reference drug for marketing approval. This paper looks at the current regulation of biosimilars in...

journal_title：Food and drug law journal

authors： Courage N,Parsons A

更新日期：2011-01-01 00:00:00

abstract：:The innovation and development incentives offered by the patent system are mitigated if a substantial portion of the patent term is lost while obtaining product approval through the Food and Drug Administration (FDA). The Drug Price Competition and Patent Restoration Act was enacted to return some of the lost patent t...

journal_title：Food and drug law journal

authors： Gaudry KS

更新日期：2011-01-01 00:00:00

abstract：:It now is possible to detect many substances in the parts per trillion and further advances will allow for even lower levels of detection. Many of these substances may always have been present in the food supply, but escaped detection. Others may have been introduced through environmental contamination, changes in foo...

journal_title：Food and drug law journal

authors： Hahn MJ

更新日期：2010-01-01 00:00:00

abstract：:FDA's recent use of the Application Integrity Policy (AIP), most notably in the ongoing Ranbaxy matter, has created interest in the policy. The article discusses actions CDER's Office of Compliance is currently undertaking to raise awareness of the AIP and establish the Office of Compliance as CDER's clearing-house fo...

journal_title：Food and drug law journal

authors： Katz PR

更新日期：2010-01-01 00:00:00

abstract：:Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009 with the aim of reducing tobacco-related illnesses and deaths by curbing tobacco's appeal to and use by children and adolescents. Legislators considered provisions of the FSPTCA restricting tobacco advertising and labeling key to realizing t...

journal_title：Food and drug law journal

authors： Stoll E

更新日期：2010-01-01 00:00:00

abstract：:Animal cloning is "complex process that lets one exactly copy the genetic, or inherited, traits of an animal." In 1997, Dolly the sheep was the first animal cloned and since then "scientists have used animal cloning to breed dairy cows, beef cattle, poultry, hogs and other species of livestock." Cloned animals are hig...

journal_title：Food and drug law journal

authors： Butler JE

更新日期：2009-01-01 00:00:00

abstract：:This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work. ...

journal_title：Food and drug law journal

authors： Lietzan EK

更新日期：2004-01-01 00:00:00

abstract：:Developing countries seeking to expand their exports often turn to food exports and seek to market these products in developed countries such as the United States. To be successful, developing countries must overcome an array of obstacles, including the need to comply with the food safety and other requirements of the...

journal_title：Food and drug law journal

authors： Horton LR

更新日期：1998-01-01 00:00:00